North Rhine-Westphalia Chemistry to Discuss Biocidal Product Authorization of Ethanol

Troisdorf, November 28, 2025 As a subsidiary of Nölken Hygiene Products GmbH, NW-Chemie has been committed to safe and effective hygiene products for decades. The current discussion regarding a possible classification of ethanol as reproductively toxic and carcinogenic under the EU Biocidal Products Regulation is causing uncertainty among users in clinics, practices, and industry. We would like to explain the facts, highlight the potential consequences, and present our position.

Ethanol as a disinfectant active ingredient - proven and indispensable

Ethanol – also known as drinking alcohol – is a cell poison. It is precisely this property that makes the substance an effective active ingredient against bacteria, yeasts, and viruses. In alcoholic hand sanitizers, ethanol works quickly, reliably, and is one of the few active ingredients that inactivates even non-enveloped viruses in a short time. NW-Chemie has been using ethanol in several formulations of the RHEOSOL and RHEOSEPT brands for many years, thereby ensuring compliance with high hygiene standards in hospitals and other sensitive areas.

EU procedures create uncertainty

Under the Biocidal Products Regulation (EU No. 528/2012), all active substances used in biocides must be approved. This process for ethanol has been ongoing since the 1990s. The responsible European Chemicals Agency (ECHA) examines not only efficacy but also risks to health and the environment.

In late November 2025, the Biocidal Products Committee (BPC) discussed the approval of ethanol. The issue at hand was whether the active substance should be classified as reproductive toxicant category 2 or even CMR category 1. A classification of this kind would entail drastic restrictions on use, particularly for hand disinfectants.

The BPC could not agree on a recommendation, and the decision was postponed until May 2026. For manufacturers like NW-Chemie, this means we cannot finalize the registrations of our established RHEOSEPT and RHEOSOL products and will not have long-term legal certainty. This situation stifles innovation and burdens investment decisions.

Public health and industry consequences

If ethanol were classified as a CMR substance, disinfectants based on it would effectively be banned. Even for professional users, temporary exemptions would have to be obtained on a case-by-case basis. Such a regulation would have far-reaching consequences. Ethanol is one of the few active ingredients that acts quickly against a broad spectrum of pathogens. If it were no longer available, effective hand disinfection in hospitals, care facilities, laboratories, and food production would only be possible to a limited extent – the hygiene chain would be jeopardized. Furthermore, without clear authorization, manufacturers cannot conclude long-term supply contracts. The lack of predictability jeopardizes supply security throughout Europe. In addition, numerous active ingredients have been waiting for authorization for years. The stalled implementation of the Biocidal Products Regulation is perceived as a step backward by many stakeholders. Further tightening would further inhibit research and development.

Our Position and Demands

NW-Chemie supports the demands of numerous clinics, associations, and research institutions that have spoken out in favor of preserving ethanol in a petition. Together with representatives from industry, medicine, and research, we will participate in the European Biocides Congress „Biocides Europe“ in Vienna next week. From our perspective, the following points are crucial:

1. Scientific assessmentThe classification of ethanol must not be based on data derived from misuse or oral intake. For use as a disinfectant, skin and inhalation exposures are low and have been classified as safe for decades. Any regulation should take these differences into account.
2. Legal certainty and transparencyManufacturers need reliable framework conditions. A process that drags on for decades and offers no clear perspective erodes trust and prevents investment. We demand a swift, transparent decision based on current scientific findings.
3. Receipt of infection preventionEthanol is difficult to replace due to its unique properties. While alternative active ingredients exist, they have limitations in efficacy, skin compatibility, or availability depending on the substance. In the event of non-approval, we have developed alternative formulations, but the reliable use of ethanol should be maintained.
4. Practical RegulationEven if the EU decides on a CMR classification, pragmatic transitional periods and exemptions must be provided. Otherwise, hospitals and other facilities may not be able to guarantee their hygiene standards in the short term.

As a responsible manufacturer, we stand for transparency and dialogue. We keep our customers informed about the current status and have alternative products available if needed. Ethanol is a proven, effective, and indispensable component of infection prevention. Balanced regulation must take this circumstance into account while simultaneously strengthening confidence in the safety and efficacy of our products. We appeal to decision-makers to consider the scientific consensus and the practical significance of ethanol as a biocide active ingredient for public health in their evaluation.